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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namehemostatic agent
Regulation Number878.4490
PMA NumberP810006
Supplement NumberS019
Date Received07/26/1995
Decision Date09/12/1995
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization facility for collastat microfibrillar hemostatic sponge at griffith microscience, inc. 27 park road, glen falls, ny 12801.